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Table 3 Clinical adverse events potentially associated with complicated diarrhea (safety population)

From: Patterns of occurrence and implications of neratinib-associated diarrhea in patients with HER2-positive breast cancer: analyses from the randomized phase III ExteNET trial

Adverse event, N (%) Neratinib (N = 1408) Placebo (N = 1408)
Grade 1 Grade 2 Grade 3 Grade 4 Grade 1 Grade 2 Grade 3 Grade 4
Nausea 439 (31.2) 140 (9.9) 26 (1.8) 0 269 (19.1) 32 (2.3) 2 (0.1) 0
Vomitinga 221 (15.7) 101 (7.2) 47 (3.3) 0 86 (6.1) 21 (1.5) 5 (0.4) 0
Fatiguea 256 (18.2) 103 (7.3) 23 (1.6) 0 214 (15.2) 62 (4.4) 6 (0.4) 0
Abdominal paina 232 (16.5) 82 (5.8) 24 (1.7) 0 119 (8.5) 22 (1.6) 3 (0.2) 0
Abdominal pain upper 160 (11.4) 41 (2.9) 11 (0.8) 0 85 (6.0) 8 (0.6) 3 (0.2) 0
Decreased appetitea 136 (9.7) 30 (2.1) 3 (0.2) 0 34 (2.4) 6 (0.4) 0 0
Weight decreased 44 (3.1) 23 (1.6) 1 (0.1) 0 5 (0.4) 2 (0.1) 0 0
Pyrexia 66 (4.7) 13 (0.9) 0 0 47 (3.3) 8 (0.6) 0 0
Dehydration 12 (0.9) 26 (1.8) 12 (0.9) 1 (0.1) 2 (0.1) 2 (0.1) 1 (0.1) 0
Neutropenia 5 (0.4) 13 (0.9) 0 1 (0.1) 7 (0.5) 4 (0.3) 2 (0.1) 0
Nephrotoxicity 13 (0.9) 5 (0.4) 7 (0.5) 1 (0.1) 4 (0.3) 2 (0.1) 0 0
 Blood creatinine increased 9 (0.6) 3 (0.2) 1 (0.1) 1 (0.1) 3 (0.2) 1 (0.1) 0 0
 Blood urea increased 1 (0.1) 1 (0.1) 1 (0.1) 0 0 0 0 0
 Glomerular filtration rate decreased 1 (0.1) 0 0 0 0 0 0 0
 Protein urine present 0 0 0 0 0 1 (0.1) 0 0
 Renal failure 0 1 (0.1) 3 (0.2) 0 0 0 0 0
 Acute renal failure 1 (0.1) 1 (0.1) 3 (0.2) 0 0 0 0 0
 Renal function test abnormal 1 (0.1) 0 0 0 0 0 0 0
 Renal impairment 0 0 0 0 1 (0.1) 0 0 0
Hypokalemia 17 (1.2) 0 4 (0.3) 1 (0.1) 11 (0.8) 0 5 (0.4) 0
Hyponatremia 4 (0.3) 0 5 (0.4) 0 2 (0.1) 0 5 (0.4) 2 (0.1)
  1. aMissing grades: vomiting (placebo, n = 1), fatigue (placebo, n = 1), abdominal pain (neratinib, n = 2), and decreased appetite (neratinib, n = 1)